Dataset from Accurate, Sensitive and Affordable POC and At Home Testing Device

Background: The purpose of this study was to test the performance (usability, feasibility, and safety) of the Saliva Test device in detecting SARS-CoV-2 in symptomatic people for Emergency Use Authorization (EUA) as a point-of-care test.

Materials/Methods: The 2322 Saliva Test was a rapid real-time RT-PCR test intended for the qualitative detection of RNA from the SARS-CoV-2 virus in saliva specimens from individuals suspected of SARS-CoV-2 infection by a healthcare professional. There were three studies under the banner of 2322 (2322a, 2322b1, and 2322b2). The test device underwent algorithmic changes after 2322a and thus was renamed 2322b. After partial enrollment eligibility criteria widened, the 2322b study adopted a 1 or 2 to designate the change in eligibility. No device performance data were included in the dataset.

Outcome/Impact: Developed from this study was the MicroGEM Spitfire6830 Saliva Test, a fully integrated point of need instrument that automates and integrates sample preparation, nucleic acid extraction, reverse transcription, and quantitative polymerase chain reaction (qPCR) amplification and detection of the target sequences present in saliva specimens.